Senior CQV Engineer - Brisbane

POSITION SUMMARY:

We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract.The Senior CQV Engineer is responsible for
ensuring systems, facilities, and equipment meet design requirements to be put
in place for a facility. The incumbent is also responsible and accountable for
the execution of the PSC mission, “to maintain the integrity and
professionalism of our products and services while enabling steady growth and
development.”

Requirements

• Bachelor’s Degree in Engineering
  or Life Science.
  
• 7-10 years of applicable work
  experience in the biomedical and pharmaceuticals industry.
  
• Proficient in authoring and
  executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
  
• Proficient in developing SOPS,
  final reports and validation & quality policies.
  
• Strong experience developing and
  executing CQV protocols.
  
• Strong experience creating and
  maintaining CQV policies and processes.
  
• Has good understanding and
  complies to cGMPs and CFR21 Part 11 guidelines.
  
• Demonstrated strategic thinking
  and implementation skills; proven analytical skills with ability to translate.
  Data to actionable plans; demonstrated ability to develop and implement
  marketing and product/service. strategies by converting them into tactical
  marketing plans; execute and deliver results.
  
• Excellent presentation and
  communication skills, written and oral, for a variety of audiences.
  
• ​Highly organized in planning and
  time management, with the ability to multi-task.